Back to resultsA Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ipragliflozin
DPP-4 inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Dipeptidyl peptidase-4 inhibitor, ASP1941, DPP-4 inhibitor, long-term safety, Diabetes mellitus
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetic patients receiving with DPP-4 inhibitor mono-therapy for at least 4 weeks
- HbA1c value between 6.5 and 9.5%
- Body Mass Index (BMI) 20.0 - 45.0 kg/m2
Exclusion Criteria:
- Type 1 diabetes mellitus patients
- Serum creatinine > upper limit of normal
- Proteinuria (albumin/creatinine ratio > 300mg/g)
- Dysuria and/or urinary tract infection, genital infection
- Significant renal, hepatic or cardiovascular diseases
- Severe gastrointestinal diseases
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASP group
Arm Description
Concomitant administration of ASP1941 and DPP-4 inhibitor
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c
Secondary Outcome Measures
Change from baseline in fasting plasma glucose
Change from baseline in fasting serum insulin
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01242228
Brief Title
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients
Official Title
Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With a Dipeptidyl Peptidase-4 Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With a Dipeptidyl Peptidase-4 Inhibitor Alone
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 21, 2010 (Actual)
Primary Completion Date
June 6, 2012 (Actual)
Study Completion Date
June 6, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.
Detailed Description
This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on a DPP-4 inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Dipeptidyl peptidase-4 inhibitor, ASP1941, DPP-4 inhibitor, long-term safety, Diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP group
Arm Type
Experimental
Arm Description
Concomitant administration of ASP1941 and DPP-4 inhibitor
Intervention Type
Drug
Intervention Name(s)
ipragliflozin
Other Intervention Name(s)
ASP1941
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
DPP-4 inhibitor
Other Intervention Name(s)
saxagliptin, alogliptin, sitagliptin, vildagliptin
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
baseline and 52 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in fasting plasma glucose
Time Frame
baseline and 52 weeks
Title
Change from baseline in fasting serum insulin
Time Frame
baseline and 52 weeks
Title
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
Time Frame
for 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetic patients receiving with DPP-4 inhibitor mono-therapy for at least 4 weeks
HbA1c value between 6.5 and 9.5%
Body Mass Index (BMI) 20.0 - 45.0 kg/m2
Exclusion Criteria:
Type 1 diabetes mellitus patients
Serum creatinine > upper limit of normal
Proteinuria (albumin/creatinine ratio > 300mg/g)
Dysuria and/or urinary tract infection, genital infection
Significant renal, hepatic or cardiovascular diseases
Severe gastrointestinal diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyushu
Country
Japan
City
Touhoku
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=104
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients
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